Studieoverzicht - 2013-07 mastectomie

A prospective non-inferiority multicentre cohort study.

Patient group:

Clinically T1-2N0 invasive breast cancer patients undergoing a mastectomy with a minimum of 1 micro- and a maximum of 3 macrometastatic axillary sentinel lymph nodes (pN1mi / pN1).

Intervention - Eligible patients will be treated according following treatment groups:
Arm A - control arm: mastectomy with completion axillary treatment
Arm B - study arm: mastectomy without completion axillary treatment

- Stratification:
Patients will be stratified by: age (≤50, 50≤75, >75), oestrogen receptor status (positive vs. negative), HER2neu status (amplified vs. not-amplified), lymph node metastasis (micro vs. macrometastasis), clinical tumour size prior to any treatment (<3cm vs. ≥3cm), grading (grade I-II vs. III - according to
modified Bloom-Richardson grading system), neoadjuvant systemic therapy and participating center.

Primary objective:

The primary objective of this study is to investigate whether omitting completion axillary treatment is not inferior to the current axillary treatment regimens in sentinel node positive breast cancer patients undergoing a mastectomy, in terms of regional recurrence rate.

Secondary objectives:

Secondary objectives of this study are to investigate whether omitting completion axillary treatment is not inferior to the current axillary treatment regimes in sentinel node positive breast cancer patients undergoing a mastectomy, in terms of distant-disease free survival, overall survival rate, the local recurrence rate and the occurrence of contralateral breast cancer. Other secondary objectives are the administration of postoperative radiotherapy and the influence of omitting completion axillary treatment on the number of
delayed axillary lymph node dissections, the axillary morbidity rate and quality of life.

Primary endpoint:

Regional recurrence rate.

Secondary endpoints:

Regional recurrence free survival, number of delayed axillary lymph node dissections, distant-disease free survival, overall survival, local recurrence rate, other-regional recurrence rate, contralateral breast cancer rate, percentage difference in the administration of postoperative radiotherapy, axillary morbidity rate, quality of life.

Inclusion criteria:

1. Female
2. Aged 18 years or older
3. Pathologically confirmed invasive unilateral breast carcinoma
4. A clinical T1-2 tumour (including multifocal or multicentric breast cancer)
5. Will be or is treated with mastectomy
6. Clinically node negative: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
7. SLN procedure and its pathologic evaluation should be performed according to the Dutch breast cancer guideline
8. pN1mi(sn) or pN1(sn): at least one and a maximum of three axillary sentinel lymph nodes containing micro- and/or macrometastases
9. Written informed consent

Furthermore, neoadjuvant systemic therapy and primary and secondary breast reconstructions are also allowed.

Exclusion criteria:

1. Clinically node positive pre-operative
2. Sentinel lymph nodes only containing isolated tumour cells (<0.2mm)
3. Solitary parasternal sentinel lymph node metastasis (pN1b)
4. Bilateral breast cancer
5.Irradical resection of primary tumour at time of registration (applicable in case the mastectomy is      performed before registration)

6. Evidence of metastatic disease
7. History of invasive breast cancer
8. Previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
9. Pregnant or nursing
10. Other prior malignancies within the past 5 years (except successfully treated basal cell and squamous cell skin cancer, carcinoma in situ of the cervix or carcinoma in situ of the ipsilateral or contralateral breast) or unsuccessfully treated malignancies > 5 years before registration
11. Unable or unwilling to give informed consent

BOOG 2013-07 Protocol synopsis versie 1.2

Film; "Hoe bespreek ik de BOOG 2013-07 studie met mijn patiënt?" 

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